Ocular Adverse Events Induced by Immune Checkpoint Inhibitors: A Comprehensive Pharmacovigilance Analysis

Area of Science:

• Ophthalmology
• Oncology
• Pharmacovigilance

Background:

• Immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment.
• Ocular adverse events (oAEs) are a known, though infrequent, complication of ICI therapy.
• Understanding the specific oAEs and associated risk factors is crucial for patient management.

Purpose of the Study:

• To characterize the spectrum and frequency of ocular adverse events (oAEs) associated with immune checkpoint inhibitors (ICIs).
• To identify specific ICI regimens and cancer types associated with a higher risk of oAEs, particularly uveitis.

Main Methods:

• Retrospective analysis of 41,674 cancer patients from the FDA Adverse Event Reporting System (FAERS) database.
• Evaluation of patients receiving anti-PD-1/PD-L1, anti-CTLA-4, or combination ICI therapy.
• Utilized Reporting Odds Ratio (ROR) to assess the rate of oAEs across different regimens and indications.

Main Results:

• 3.0% of patients (1,268) reported oAEs, most commonly vision disorders (30.8%) and uveitis (15.1%).
• Melanoma patients showed a higher proportion of uveitis (1.2%) compared to other indications.
• Combination anti-PD-1 and anti-CTLA-4 therapy significantly increased the risk of uveitis (ROR 17.1) compared to anti-PD-1/PD-L1 monotherapy (ROR 4.77).

Conclusions:

• ICI-induced oAEs are rare, affecting approximately 3% of patients.
• Uveitis is a significant oAE, with its occurrence strongly associated with melanoma and the combination of anti-PD-1 and anti-CTLA-4 inhibitors.
• Risk stratification and vigilant monitoring are essential for patients on ICIs, especially those with melanoma receiving combination therapy.